I 1111111111111111 1111111111 111111111111111 111111111111111 lll111111111111111
`US010413745B2
`
`c12) United States Patent
`Riehl
`
`US 10,413,745 B2
`(IO) Patent No.:
`*Sep.17,2019
`(45) Date of Patent:
`
`(54) REDUCING DISCOMFORT CAUSED BY
`ELECTRICAL STIMULATION
`
`(75)
`
`Inventor: Mark Edward Riehl, Doylestown, PA
`(US)
`
`FOREIGN PATENT DOCUMENTS
`
`EP
`EP
`
`12/1999
`0966988 Al
`12/2000
`0998958 A3
`(Continued)
`
`(73) Assignee: Neuronetics, Inc., Malvern, PA (US)
`
`OTHER PUBLICATIONS
`
`( *) Notice:
`
`Subject to any disclaimer, the term ofthis
`patent is extended or adjusted under 35
`U.S.C. 154(b) by 674 days.
`
`This patent is subject to a terminal dis(cid:173)
`claimer.
`
`Hess, C.W. et al., "Magnetic Stimulation of the Human Brain:
`Influence of Size and Shape of the Stimulating Coil", Motor
`Disturbances II, 1988, 31-42.
`(Continued)
`
`(21) Appl. No.: 10/672,833
`
`(22) Filed:
`
`Sep. 26, 2003
`
`(65)
`
`Prior Publication Data
`
`US 2004/0193000 Al
`
`Sep. 30, 2004
`
`Related U.S. Application Data
`
`(63) Continuation of application No. 10/657,296, filed on
`Sep. 8, 2003, now Pat. No. 7,153,256.
`(Continued)
`
`(51)
`
`Int. Cl.
`A61N 2100
`(52) U.S. Cl.
`CPC ............. A61N 21008 (2013.01); A61N 21006
`(2013.01)
`
`(2006.01)
`
`( 58) Field of Classification Search
`CPC .......... A61N 2/006; A61N 2/02; A61N 2/008;
`A61N 1/40; A61N 1/36071;
`(Continued)
`
`(56)
`
`References Cited
`
`U.S. PATENT DOCUMENTS
`
`3,658,051 A
`3,683,923 A
`
`4/1972 MacLean
`8/ 1972 Anderson
`(Continued)
`
`128/303.14
`
`Primary Examiner - Christine H Matthews
`(74) Attorney, Agent, or Firm - Condo Roccia Koptiw
`LLP
`
`(57)
`
`ABSTRACT
`
`The invention is directed to a novel method for reducing
`discomfort caused by transcutaneous stimulation. The novel
`method includes providing transcutaneous stimulation,
`reducing the transcutaneous stimulation at a first location,
`and substantially maintaining the transcutaneous stimulation
`at a second location. The transcutaneous stimulation may be
`created by electric and/or magnetic fields. The first location
`may be relatively proximate to the cutaneous surface and
`may comprise tissue, nerves and muscle. Also, the second
`location may be relatively deeper than the first location and
`include, for example, brain tissue that requires the transcu(cid:173)
`taneous stimulation for treatment purposes. The invention
`further may include locating a conductor on a treatment area
`and/or a transcutaneous stimulation device relative to the
`first location. In addition, the method may further include
`adjusting how much the transcutaneous stimulation is
`reduced at the first location.
`
`66 Claims, 26 Drawing Sheets
`
`101
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`102
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`104
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`Allergan EX1067
`Page 1
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`

`

`US 10,413,745 B2
`Page 2
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`Related U.S. Application Data
`
`(60)
`
`(58)
`
`Provisional application No. 60/452,477, filed on Mar.
`7, 2003.
`Field of Classification Search
`CPC ............ A61N 1/36082; A61N 1/36014; A61N
`1/36025; A61N 1/0529; A61N 1/0534
`USPC .................................................. 600/9-15, 37
`See application file for complete search history.
`
`(56)
`
`References Cited
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`

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`US 10,413,745 B2
`Page 3
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`Allergan EX1067
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`

`

`US 10,413,745 B2
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`Allergan EX1067
`Page 4
`
`

`

`U.S. Patent
`
`Sep.17,2019
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`Allergan EX1067
`Page 6
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`

`

`U.S. Patent
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`Sep.17,2019
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`Allergan EX1067
`Page 7
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`

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`U.S. Patent
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`Sep.17,2019
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`Page 8
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`

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`U.S. Patent
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`Sep.17,2019
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`Allergan EX1067
`Page 9
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`

`

`U.S. Patent
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`Sep.17,2019
`
`Sheet 6 of 26
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`US 10,413,745 B2
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`507
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`
`Allergan EX1067
`Page 10
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`

`

`U.S. Patent
`
`Sep.17,2019
`
`Sheet 7 of 26
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`US 10,413,745 B2
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`
`Allergan EX1067
`Page 11
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`

`

`U.S. Patent
`
`Sep.17,2019
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`Sheet 8 of 26
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`Allergan EX1067
`Page 12
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`

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`U.S. Patent
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`Sep.17,2019
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`Sheet 9 of 26
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`
`Allergan EX1067
`Page 13
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`

`

`U.S. Patent
`
`Sep.17,2019
`
`Sheet 10 of 26
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`US 10,413,745 B2
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`900
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`901
`Applying a flexible circuit pad to the
`treatment area (i.e., patient or magnetic
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`patient.
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`Figure 9
`
`Allergan EX1067
`Page 14
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`

`

`U.S. Patent
`
`Sep.17,2019
`
`Sheet 11 of 26
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`US 10,413,745 B2
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`Figure 10
`
`Allergan EX1067
`Page 15
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`

`

`U.S. Patent
`
`Sep.17,2019
`
`Sheet 12 of 26
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`Allergan EX1067
`Page 16
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`

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`Sep.17,2019
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`Sheet 13 of 26
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`Allergan EX1067
`Page 17
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`

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`U.S. Patent
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`Sep.17,2019
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`Sheet 14 of 26
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`Allergan EX1067
`Page 18
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`

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`Sep.17,2019
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`Sheet 15 of 26
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`Allergan EX1067
`Page 19
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`U.S. Patent
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`Sep.17,2019
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`Sheet 20 of 26
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`Page 24
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`Allergan EX1067
`Page 25
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`

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`Page 26
`
`

`

`U.S. Patent
`
`Sep.17,2019
`
`Sheet 23 of 26
`
`US 10,413,745 B2
`
`Surface plot of total E - no Cancellation
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`Allergan EX1067
`Page 27
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`U.S. Patent
`
`Sep.17,2019
`
`Sheet 24 of 26
`
`US 10,413,745 B2
`
`Surface plot of total E - with Cancellation
`
`6
`
`(.)
`
`8 4
`~
`r:,::j'2
`
`I
`I
`I
`I
`-1--
`- - I
`I
`I
`I
`-1--
`- - I
`I
`I
`I
`1.,--
`
`-- '
`
`Vertical Position, cm
`
`0
`
`0
`
`Azimuthal Angle, degrees
`
`Contour of E, with Cancellation
`
`10
`
`20
`
`30
`
`50
`40
`E, V/cm
`
`60
`
`70
`
`80
`
`nw-fl*~1*-;~:1~cft.~~tf.}:;-
`1
`2
`3
`4
`5
`-··-··-··-··-··-t----------+-··-··--·-··-··-+------
`
`!F.IY, 22@
`
`Allergan EX1067
`Page 28
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`

`

`UI = N
`
`~
`~
`"'""' w
`"'""' = ~
`d r.,;_
`
`V electrode B to -B is 3. 37 V
`V elec,trode A to -A is 1. 86 V
`
`0 ....
`
`O'I
`N
`
`Ul
`N
`.....
`rJJ =(cid:173)
`
`('D
`('D
`
`!F.l(l. JJ
`
`0 ....
`'? ....
`
`1,0
`
`N
`~-....J
`
`('D
`rJJ
`
`~ 2304
`
`2.52"-~
`
`2302 Electrode -A ~
`
`~ T Electrode A
`
`~3
`
`Electrode B
`
`:J
`
`Electrode B r -2.5"
`
`~
`
`Electrode -B
`
`Electrode -B
`::J
`
`230~
`
`3.125" 1.625" 1 1~
`2305 It::
`
`~ = ~
`
`~
`~
`~
`•
`00
`
`e •
`
`All electrodes are 1/8" high
`
`Electrodes~
`
`ylx
`
`Allergan EX1067
`Page 29
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`

`

`UI = N
`
`~
`~
`"'""' w
`"'""' = ~
`d r.,;_
`
`0 ....
`
`O'I
`N
`
`O'I
`N
`
`('D ....
`rJJ =(cid:173)
`
`('D
`
`0 ....
`'? ....
`
`1,0
`
`N
`~-...J
`
`('D
`rJJ
`
`~ = ~
`
`~
`~
`~
`•
`00
`
`e •
`
`200
`
`200
`
`:
`
`150
`
`I
`
`Time, µs
`.
`
`100
`
`I
`
`50
`
`0
`
`-6
`
`-------~----------'------
`
`I
`
`I
`
`----=;-----t------
`-r----
`
`.//
`,,,
`
`I
`:
`
`I
`
`:
`;
`l''--
`~----------..! ____ _
`
`I
`I
`
`---
`
`------,--------
`
`I
`I
`
`I
`I
`1
`I
`I
`I
`
`I
`
`-----
`
`7----------I____
`
`I
`I
`I
`
`--
`
`~ -4 ----------'---~==::-:~;::::..,-:
`&:i
`b
`. 0 -2 ----------_.:::,.______
`-8
`~ 0
`0
`+>
`G>
`= 2
`;,jj
`~
`-4
`>
`
`!F/Y, 24
`
`Two electrodes B
`1 -
`--Two electrodes A
`-One electrode
`
`Electrode Potential
`
`6
`
`200
`-3000-1-------1-----4---.:::::::::====i-----l------1
`-2000 ----------~---------~---------~-
`
`200
`
`150
`
`une, µs
`
`100 T.
`
`------~----------
`
`I
`
`I
`
`50
`
`!
`
`0
`
`I
`
`I
`
`I
`
`I
`
`0 -1000 __________ L _________ J _________ L ________ J _________ _
`o ----------1---------~----------r---------:------
`~
`1 1000 ---------~--------1----------~---------~----------
`< 2000 ---------:---------~----------~----------:-------
`-------1----------t---------~-------
`
`I
`
`I
`
`-
`
`I
`Core Current
`
`3000
`4000
`
`I
`
`I
`
`I
`
`I
`
`Allergan EX1067
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`

`

`US 10,413,745 B2
`
`1
`REDUCING DISCOMFORT CAUSED BY
`ELECTRICAL STIMULATION
`
`CROSS-REFERENCE TO RELATED
`APPLICATION
`
`This application claims priority under 35 U.S.C. § 119 (e)
`from U.S. provisional application Ser. No. 60/452,477, filed
`on Mar. 7, 2003, entitled "Device, Method, and System for
`the Reduction of Discomfort Associated with and Facilitat(cid:173)
`ing Treatment via Magnetic Stimulation," which is herein
`incorporated by reference in its entirety. This application is
`a continuation of U.S. patent application Ser. No. 10/657,
`296, filed Sep. 8, 2003, entitled "Reducing Discomfort
`Caused by Electrical Stimulation," which is herein incorpo(cid:173)
`rated by reference in its entirety.
`
`FIELD OF THE INVENTION
`
`2
`panic disorders, just to name a few. One particular condition,
`depression, is the often referred to as the "common cold" of
`psychiatric disorders, believed to affect 19 million people in
`the United States alone, and possibly 340 million people
`5 worldwide. Modem medicine offers depression patients a
`number of treatment options, including several classes of
`anti-depressant medications
`like
`selective
`serotonin
`reuptake inhibitors (SSRI), MAis, tricyclics, lithium, and
`electroconvulsive therapy (ECT). Yet many patients remain
`10 without satisfactory relief from the symptoms of depression.
`To date, ECT remains the "gold standard" of treatments for
`severe depression; however, many patients will not undergo
`the procedure because of its severe side effects.
`Recently, repetitive transcranial magnetic stimulation
`15 (rTMS) has been shown to have significant anti-depressant
`effects for patients, even those that do not respond to the
`traditional methods and medications. In one embodiment of
`rTMS, a subconvulsive stimulation is applied to the pre-
`frontal cortex in a repetitive manner, causing a depolariza(cid:173)
`tion of cortical neuron membranes. The membranes are
`depolarized by the induction of small electric fields, usually
`in excess of 1 volt per centimeter (V/cm). These small
`electric fields result from a rapidly changing magnetic field
`applied non-invasively.
`It is now well known to those skilled in the art that both
`the left and right prefrontal cortex regions of the brain have
`strong communication links to Limbic System structures,
`which contain the "circuits" controlling mood and general
`behavior. One objective of rTMS is to provide stimulation to
`30 these biological circuits through a non-invasive, sub-con(cid:173)
`vulsive technique to relieve the symptoms of depression
`without many of the negative side effects of ECT or medi(cid:173)
`cations. However, one reported side effect of rTMS for the
`treatment of depression is patient discomfort at the site of the
`35 stimulation. This discomfort is caused, in part, by the
`depolarization of neuron membranes in the scalp and the
`resulting scalp muscle contractions that occur at the fre(cid:173)
`quency of the rTMS. Testing ha